title: Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review.
abstract: BACKGROUND
  Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published.
  
  
  METHODS
  We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature.
  
  
  RESULTS
  This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting.
  
  
  CONCLUSIONS
  Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.
authors.affiliation: Canadian Agency for Drugs and Technologies in Health, 600-865 Carling Ave, Ottawa, Ontario, K1S 5S8, Canada. juliep@cadth.ca.
authors.forename: Julie
authors.initials: J
authors.lastname: Polisena
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Forster
authors.forename: Karen
authors.initials: K
authors.lastname: Cimon
authors.forename: Danielle
authors.initials: D
authors.lastname: Rabb
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D015706:Bibliometrics; D062906:Cardiac Catheters / Q000009:adverse effects*; D004868:Equipment Failure; D006801:Humans; D016247:Information Storage and Retrieval; D011358:Product Surveillance, Postmarketing